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Process Development Engineer - Miami Lakes, United States - DemeTech
1 week ago
Description
Job DescriptionJob DescriptionResponsibilities:
Write engineering justification memos.
Analyze Design problems or deficiencies and develop solutions to resolve them.
Aspects of the product design and development of a project with a focus on innovative implantable medical devices that address the customer needs for a complete procedural solution.
Plan, coordinate, and direct the application of Quality Engineering practices for New Product Development (NPD) and Design Transfer teams on a project basis from concept to commercialization.
Work within a cross-functional project team through all phases of the product development process, planning and executing projects through the product launch.
Manage the quality of the technical team's implementation of incoming inspection, calibration, and inventory control systems.
Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed.
Involved in test method development and testing of the proposed design.
Work with manufacturing engineering and suppliers to optimize designs for manufacturability and produce prototypes.
Develop an expert knowledge of our product lines and detailed knowledge of various anatomies and pathologies.
Education:
A bachelor's degree is required; preferably in Mechanical, Biomedical, Electrical, or Automation Engineering discipline.
Communication skills:
Good written and oral English communication skills.
Technical Proficiencies:
Organizational Skills, Presentation Skills, Project Management, Results Driven, Mathematical Skills, Technical Capacity, Thoroughness, Time Management.
Judgment and Decision Making:
Capable of working independently on assigned project activities in a cross functional team environment. Must possess a good understanding of engineering fundamentals.
Experience:
Experienced in Medical Device product development process. Good Understanding of Design history file (DHF) / Technical Documentation. Good understanding of ISO Management principles. Experience with prototype design / fixture design and performing functional testing.
Experience with Design V&V, writing protocols, Testing, results analysis, application of statistical techniques, Report preparation.
Experience in the ECR / ECO process and also proficient with PLM system (e.g., Agile / windchill or any similar PLM tool).
Must be proficient in Fusion 360 / SolidWorks.Experience in product design, process development, automation, PLC, HMI, pneumatics, Process Control, device testing or prototyping- Capable of applying standard statistical practices and techniques in specific situations, and to adjust and correlate data and recognize discrepancies in results.
Company DescriptionDemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.Company DescriptionDemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.
